MAUDE Adverse Event Report: PENUMBRA, INC. RUBY COIL; HCG, KRD

Catalog Number	RBY4C0630
Medical Device Problem Codes	Detachment Of Device Component (1104); Unraveled Material (1664)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Results: the pet lock was intact on the proximal end of the ruby coil pusher assembly.The pusher assembly was kinked in multiple locations throughout its length.The embolization coil was detached from the pusher assembly and unraveled, and the stretch resistant wire (sr wire) was fractured.Conclusions: evaluation of the returned device revealed that the sr wire was fractured and the embolization coil was detached.Fracture of the sr wire typically occurs due to forceful retraction of the ruby coil against resistance, and will allow the embolization coil to detach from the pusher assembly.The unraveling of the detached embolization coil may have occurred due to manipulation of the ruby coil after the sr wire fractured, and the unraveling was likely furthered during attempts to retrieve the coil with a snare.The lantern mentioned in the complaint was not returned for evaluation.Penumbra coils and catheters are inspected during in-process inspection and during quality inspection after manufacturing.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the internal iliac vein using ruby coils.It was noted that the patient's anatomy had some tortuosity.During the procedure, while attempting to advance a ruby coil into the target vessel using a lantern delivery microcatheter (lantern), the physician did not mention resistance; however, the ruby coil unintentionally detached with part of the coil in the lantern and the other part in the coil mass.The physician then removed the lantern and the detached coil remained in the patient¿s body.Next, the physician attempted to remove the detached coil by removing the access sheath but the coil broke further and began to unravel.Therefore, the physician used a snare device to remove the ruby coil in pieces.The procedure then ended after removal of the coil.There was no report of an adverse effect to the patient.

• Brand Name: RUBY COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7311635
• Report Number: 3005168196-2018-00478
• Device Sequence Number: 11325064
• Product Code: HCG
• UDI-Device Identifier: 00814548013190
• UDI-Public: 00814548013190
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K120330
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Expiration Date: 08/22/2025
• Device Catalogue Number: RBY4C0630
• Device Lot Number: F78851
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/01/2018
• Initial Report FDA Received Date: 03/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention